MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-04-29 for SAROT NEEDLE HOLDER 36-3020 * manufactured by Codman & Shurtleff, Inc..
[1977865]
A physician was using the needle holder in the heart and noticed a section of the jaw insert was missing. The sterile field and floor were searched, but it was not found. Patient was searched with x-ray.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2082488 |
| MDR Report Key | 2082488 |
| Date Received | 2011-04-29 |
| Date of Report | 2011-04-29 |
| Date of Event | 2011-04-26 |
| Report Date | 2011-04-29 |
| Date Reported to FDA | 2011-04-29 |
| Date Added to Maude | 2011-05-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAROT NEEDLE HOLDER |
| Generic Name | SAROT NEEDLE HOLDER |
| Product Code | MJG |
| Date Received | 2011-04-29 |
| Model Number | 36-3020 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-29 |